Delta-Fly Pharma, Inc. [4598.T]
TOKYO, May 11 (Pulse News Wire) – Delta-fly Pharma,inc. (4598.T) announced today that trademark registrations for “RADBALGO” and “RADGAZEN,” necessary for NDA approval of its drug candidate DFP10,917 (Radgocitabine), have been completed internationally, including China.
The trademarks, with international registration numbers 1,600,230 and 1,600,256, now allow global sales under the same brand name. Additionally, the company is preparing discussions with the FDA regarding conditional NDA submission based on positive results from clinical trials involving DFP10,917 for relapsed/refractory acute myeloid leukemia (R/R AML).
Key points of discussion include superior efficacy compared to intensive therapy, significant benefits for TP53-mutated patients, and enhanced outcomes when combined with Venetoclax. Furthermore, Delta-Fly plans to conduct an End of Phase 2 Meeting with the FDA to initiate a phase 3 trial for secondary treatment of AML patients based on promising data from a phase 1/2 combination study with Venetoclax.
The company also highlighted potential cost savings in manufacturing and reduced economic burden for patients due to DFP10,917 being a low-molecular compound compared to antibody drugs.
🟢 Confidence: High AI-translated content.